Search Results

Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

The provided text is related to a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves," not an AI-powered medical device study. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant information about the device's performance based on the provided document:

Acceptance Criteria and Device Performance

Study Details (where applicable based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. The document discusses device characteristics and meeting standards, not a test set in the context of an AI study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to this product. The 'ground truth' here refers to whether the glove met the specified standards.
3. Adjudication method for the test set: Not applicable. The "adjudication method" is not relevant to the described testing of physical characteristics and biocompatibility.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (gloves), not an AI system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (gloves), not an AI system.
6. The type of ground truth used: The 'ground truth' for the device was defined by established regulatory standards and test methods, such as ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10 for physical properties and biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Further Explanation of the Study:

The document describes a premarket notification (510(k)) where the manufacturer seeks to demonstrate that their "Powder Free Vinyl Patient Examination Gloves" are substantially equivalent to a legally marketed predicate device. This is achieved by showing that the new device meets established industry standards and FDA regulations for physical properties, freedom from pinholes, powder residual, and biocompatibility.

The "study" in this context refers to the non-clinical testing performed to demonstrate compliance with these standards. The testing methods mentioned are:

• ASTM standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
• 21 CFR 800.20: For Freedom from pinholes (waterleak test).
• ISO10993-10 / Primary Skin Irritation in rabbits: For Biocompatibility.
• ISO10993-10 / Dermal sensitization in the guinea pig: For Biocompatibility.

The conclusions from these non-clinical tests were that the Blue Sail (Brand) Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements as detailed in the table above. Clinical data was explicitly stated as "not needed for gloves or for most devices cleared by the 510(k) process" for this type of device.

Ask a specific question about this device

Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.

Acceptance Criteria and Study for Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves

This document summarizes the acceptance criteria and the study conducted to demonstrate that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves meet these criteria, as described in the provided 510(k) summary (K032783).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample sizes used for the individual tests (e.g., number of gloves tested for dimensions, physical properties, or pinholes).

The data provenance is implicit: the tests were conducted by the manufacturer, Zibo Blue Sail Chemical Co., Ltd., presumably in P.R. China, to demonstrate compliance with the specified ASTM standards and FDA regulations. The studies appear to be retrospective in nature, as they involve testing a manufactured product against established standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical parameters defined by established industry standards (ASTM) and federal regulations (CFR). There is no mention of human experts being used to establish a "ground truth" for the performance of the gloves beyond interpreting the results of standardized tests.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are based on objective measurements against defined standard limits, an adjudication method for conflicting expert opinions is not relevant. The pass/fail criteria are directly derived from the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or interpretive medical devices where human readers (e.g., radiologists) interpret images or data. Patient examination gloves are a physical barrier device, and their effectiveness is assessed through physical and biocompatibility testing, not through human interpretation of medical data.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a medical glove, not an algorithm or software. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply. The performance evaluation focuses on the physical and chemical characteristics of the glove itself.

7. Type of Ground Truth Used

The ground truth used for evaluating this device is based on objective, quantitative standards and regulatory requirements. Specifically:

• ASTM standards (D 5250-00e4 and presumably D6124-01): These standards define the acceptable ranges for physical properties (dimensions, tensile strength, elongation, puncture resistance) and powder amount.
• 21 CFR 800.20: This regulation defines the acceptable quality level (AQL) for freedom from pinholes (water leak test).
• ISO 10993-10: This international standard covers biological evaluation of medical devices, specifically for irritation and sensitization.

Essentially, the "ground truth" is defined by the pass/fail criteria specified within these published standards and regulations.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (medical glove), not an AI/ML algorithm or system that requires a "training set" in the context of machine learning. The manufacturing process is subject to quality control, but there is no "training set" of data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As established in point 8, there is no "training set" for this device. The manufacturing and testing processes follow established quality management systems and standard operating procedures to ensure consistent product quality, but this is distinct from establishing ground truth for machine learning training.

Ask a specific question about this device